Patient-Like NIPT Reference Materials
SeraCare offers a broad portfolio of patient-derived NIPT standards for assay development, validation and routine run QC. These Seraseq® reference materials help assure the quality of NIPT tests by providing external and well validated standards suitable for a wide range of assay methods.
Available for a variety of chromosomal anomalies, including trisomy 21, trisomy 18, trisomy 13, Jacobs Syndrome (XYY), Klinefelter syndrome (XXY), Turner syndrome (XO), as well as 22q11 microdeletion and euploid, SeraCare also offers custom material to suit specific needs or other genetic conditions. Developed with our novel technology, these materials preserve the maternal-fetal size profile observed in native cfDNA making these materials uniquely similar to the behavior of actual patient samples.
Click here to download our latest white paper to detailing how Seraseq® NIPT reference materials are an alternative solution for hard-to-source NIPT clinical samples on a leading platform.
Click here to download this scientific poster for more information on the development, characterization and clinical performance of our novel SNP-matched SCA reference materials.
Assay Development
Are you working on a new NIPT assay? You will need to:
- Test and optimize the protocol
- Test and determine sensitivity and specificity
- Test LOD, range of fetal fractions
- Monitor manufacturing and lot quality
Our materials are proven to expedite assay development, optimization and manufacturing.
Validation and Verification
Are you licensing a 3rd party test or expanding to new locations? Let us help you:
- Meet regulatory guidelines
- Develop a consistent benchmark
- Ensure the test performance is as expected
- Validate new reagent lots or protocol changes
We help labs quickly and effectively validate, verify and train your staff.
Routine Run QC
Do you want to save time, money and increase confidence in your results? We offer reference materials that:
- Proactively monitor assay and instrument performance
- Expedite troubleshooting
- Ensure accuracy of daily results
- Monitor the full process by using patient-like materials
Labs running our samples routinely are able to rapidly detect and respond to sample failures and ensure accuracy.
